DEVICE: SMR Shoulder (08033390097635)
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Device Identifier (DI) Information
SMR Shoulder
Glenoid Reamer
In Commercial Distribution
9013.75.165
LIMACORPORATE SPA
Glenoid Reamer
In Commercial Distribution
9013.75.165
LIMACORPORATE SPA
SMR SHOULDER - STD GLENOID REAMER
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 60927 | Glenoid orthopaedic reamer |
An orthopaedic surgical instrument designed to cut and resurface with precision the glenoid fossa for the acceptance of the glenoid fossa component of a shoulder joint prosthesis. The device is designed with a hemispherical head with an abrasive/cutting outer surface attached to a shaft for connection to a manual or powered handle. It is typically made of a high-grade stainless steel alloy and is available in various sizes. This is a reusable device intended to be sterilized prior to use.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K100858 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: # STD |
Device Record Status
6ec9c05f-18d4-42ff-b8d8-2c0ff8b239a7
January 24, 2025
4
April 07, 2016
January 24, 2025
4
April 07, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined